SUPPLY CHAIN ARTICLES
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The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies
The following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
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Can America's Retreat On mRNA Be Europe's Opportunity?
With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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Multidisciplinary mRNA: What Can We Learn From Other CGTs?
Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
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The Expanding Patent Landscape For RNA-Based Therapeutics
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward
Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.
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Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault
What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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Learn how optimized RNA polymerases enhance mRNA therapeutic quality and transcript integrity by increasing yield and capping efficiency while reducing double-stranded RNA impurities.
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Protect patient safety and ensure regulatory compliance by implementing sensitive, reliable bacterial endotoxin testing as a critical component of pharmaceutical quality assurance.
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Risk analysis and lane qualification show supply chains perform consistently, meeting regulatory expectations by demonstrating control, reducing variability, and ensuring reliable delivery.
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Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.